Pega Medical, Inc.: FDA clearances and approvals
Pega Medical, Inc. has 12 FDA 510(k) clearances (first 2003, latest 2022), across 5 product codes in 1 review panel. Median 510(k) review time: 206 days. Since 2017 its median was 184 days, against 104 days for all cleared 510(k)s in the same product codes. openFDA lists 10 product recalls by a recalling firm named Pega Medical, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 269 |
| 2013 | 1 | 180 |
| 2014 | 0 | — |
| 2015 | 1 | 228 |
| 2016 | 1 | 271 |
| 2017 | 2 | 162 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 271 |
| 2021 | 1 | 28 |
| 2022 | 1 | 273 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Pega Medical, Inc.'s cleared 510(k)s took a median 184 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 104 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | 7 | 7 |
| HRS | Plate, Fixation, Bone | 2 | 2 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 | 1 |
| OBT | Plate, Bone, Growth Control, Pediatric, Epiphysiodesis | 1 | 1 |
Review panels
- Orthopedic (12)
Most recent Pega Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220190 | The GIRO Growth Modulation System | OBT | 2022-10-24 | 273 |
| K211292 | Fassier-Duval Telescopic IM System | HSB | 2021-05-26 | 28 |
| K192710 | The Simple Locking Intramedullary (Slim) System | HSB | 2020-06-24 | 271 |
| K170704 | The Locking Pediatric Osteotomy Plate (LolliPOP) System | KTT | 2017-09-08 | 184 |
| K163003 | Y3 Proximal Femoral Plate System | HRS | 2017-03-16 | 139 |
| K160545 | GAP ENDO-EXO MEDULLARY SYSTEM | HSB | 2016-11-23 | 271 |
| K143355 | The Simple Locking IntraMedullary (SLIM) System | HSB | 2015-07-10 | 228 |
| K131591 | FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE) | HWC | 2013-11-27 | 180 |
| K111232 | GAP ENDO-EXO MEDULLARY SYSTEM | HSB | 2012-01-26 | 269 |
| K090440 | HINGE PEDIATRIC PLATING SYSTEM | HRS | 2009-05-20 | 89 |
2 earlier clearances. See the full list in Caduvo.
Recalls
10 product recalls in 10 recall events; 0 initiated in the last five years. Most recent: 2020-04-03.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Pega Medical, Inc. have?
Pega Medical, Inc. has 12 FDA 510(k) clearances (first 2003, latest 2022), across 5 product codes in 1 review panel.
How long does FDA take to clear Pega Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Pega Medical, Inc.'s cleared 510(k)s is 206 days. Since 2017: 184 days, versus 104 days for all cleared 510(k)s in the same product codes.
What devices does Pega Medical, Inc. make?
Its most frequent FDA product codes are HSB (Rod, Fixation, Intramedullary And Accessories, 7); HRS (Plate, Fixation, Bone, 2); HWC (Screw, Fixation, Bone, 1).
Has Pega Medical, Inc. had device recalls?
openFDA lists 10 product recalls in 10 recall events by a recalling firm whose name matches Pega Medical, Inc; the most recent began 2020-04-03. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 12 Pega Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HSB, Pega Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.